How to ensure good practices for documentation of safety variations
By Ea Dige
Ensuring good practices for documentation and management of safety variations, starts by optimizing the cooperation between your Regulatory Affairs (RA) and Pharmacovigilance (PV) functions.
Good practices for documentation of safety variations will support implementation of the safety finding, and being prepared for questions that may occur during a PV inspection.
According to the guidelines of Good PV Practice (GVP II.B.6), safety variations should be presented in the Pharmacovigilance System Master File (PSMF):
- Section 6: Company specific targets for key performance indicators (KPIs).
- Annex F: State actual timelines.
Your company’s good practices for variations should specify the following:
1. Timely submissions of safety variations initiated by:
– the company
– PRAC (the Pharmacovigilance Risk Assessment Committee).
2. Documentation of safety variation submission timelines.
Implementation and timeline
The targeted timeline for the implementation of the Summary of Product Characteristics and Package Leaflets (SmPCs/PLs) should be described in company procedures and in the PSMF.
This description should include:
- Timing of new PLs in the packs.
- Timing of upload of SmPCs to all public websites.
- Review and considerations regarding the potential impact of SmPC/PIL updates on other materials (educational, promotional, clinical trial related).